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Abstract

DESCRIPTION (provided by applicant): Poor medication adherence has a significant negative impact on patients, clinical study outcomes, and the healthcare system in general. As much as 25% of all healthcare costs could be avoided if patients reliably took their prescribed medications. Medication adherence is of particular concern in clinical trials. Standard measures of adherence (pill counting and diaries) are inaccurate and yet still costly, whereas the few available accurate measures of adherence (e.g. direct observed therapy) are cost prohibitive and logistically difficult to implement in large studies. In studies notorious for poor medication adherence, such as drug abuse studies, non-adherence will conceal the true outcomes of the study, including efficacy, safety, dose response, and side effects, potentially rendering the study
useless without accurate measures of medication adherence. This Fast-track SBIR project will utilize eTect's existing technology to create Smart Capsules that provide accurate and real-time adherence monitoring for clinical studies, particularly studies at high risk of low compliance. In Phase I we will develop a prototype Smart Capsule by inserting a biocompatible wireless sensor, or "tag", between a size 1 capsule inserted into a size 00 capsule. In Phase II we will develop a custom system for producing large quantities of production-ready Smart Capsules. Phase II will also include a 60 patient trial with marijuana-dependent subjects to evaluate the functionality of the Smart Capsule system, the ease by which it can be integrated into the trial processes, and it's potential to improve compliance with a targeted reminder system. The Specific Aims of the study in Phase I are to: 1. Modify the existing eTect ID-Cap Tag for optimum performance in 'capsule-in-a- capsule'(cap-in-cap) configuration 2. Design and manufacture prototype Smart Capsules 3. Evaluate the performance of prototype Smart Capsules in stability, dissolution, compatibility, and environmental tests. The Specific Aims of the study in Phase II are to: 1. Redesign the electronic tags to support high volume manufacture 2. Modify the Smart Capsule manufacturing processes to produce high volume supplies for testing and the clinical trial 3. Evaluate the Smart Capsule's performance in pilot drug abuse clinical trial
PUBLIC HEALTH RELEVANCE: Poor medication adherence has a significant negative impact on patients, clinical study outcomes, and the healthcare system in general, and current adherence monitoring techniques are inaccurate and costly. Additionally, lack of an acceptable and accurate method of measuring (and potentially improving) compliance can render the billions of dollars spent each year on clinical trials useless. We propose to develop a Smart Capsule technology for accurate measurement of adherence data in clinical studies that is cost-effective, unobtrusive for the subject, and easily embedded into the clinical study processes.